The Dream of a Pill Free Existence and the Continuous Dopaminergic Pump for the Treatment of Parkinson’s Disease
You can find out more about NPF's National Medical Director, Dr. Michael S. Okun, by also visiting the NPF Center of Excellence, University of Florida Center for Movement Disorders & Neurorestoration. Dr. Okun is also the author of the Amazon #1 Parkinson's Best Seller 10 Secrets to a Happier Life.
One of the common dreams shared by Parkinson’s disease patients around the globe is the possibility of living a pill free existence. One cannot blame the Parkinson’s disease patient or caregiver for dreaming big. A single day in Parkinson’s disease shoes is likely to reveal the need for dozens of pills administered day and night. In many cases, pills are taken as frequently as every hour or two. If you ask a Parkinson’s disease patient to place an entire pill regimen for the day into the palms of their hands, there is a better than average chance he or she will not be able to hold all of them. Previously, there was a hope that deep brain stimulation may have offered the highly sought after “pill free existence,” however over two decades into its history, it is clear that in the majority of cases, medications will still be required. There is however, another treatment strategy on the horizon. A strategy that offers the possibility of constant stimulation of the brain’s dopamine receptors through the use of a continuous dopamine infusion pump technology. In this month’s issue of Lancet Neurology the first randomized controlled trial of a continuous pump infusion technology for Parkinson’s disease has been published (online before print).
The trial utilized an intrajejunal (i.e. a tube inserted in the small intestine) levodopa-carbidopa intestinal gel pump infusion strategy, and it was designed to collect safety and effectiveness data. The study was carefully conducted and was double blind (neither the patients nor the raters knew what was administered) and randomized. It was conducted in 26 centers including Germany, New Zealand, and the US. Participants were randomized (1:1) to “immediate-release oral levodopa-carbidopa pills plus a placebo intestinal gel infusion or to levodopa-carbidopa intestinal gel infusion plus oral placebo pills.” It is important to remember that everyone in the study received a pump, but half of the patients did not receive active therapy (through the continuous pump infusion). The authors were most interested in improving the amount of time spent in the “off state” following 4 months of therapy. Off-time improved by 4 hours in the pump group versus 2.1 hours in the pill group. The amount of “on” time without troublesome dyskinesia was better in the pump group when compared to the pill group (4.1 vs. 2.2 hours).
The pump is approved and available in 43 countries. The United States has lagged behind the world in adopting this new approach to Parkinson’s disease therapy. However, in defense of the U.S.A. and the FDA, prior to the publication of the current pump trial, all previous results were based on uncontrolled evidence. The benefits of the pump have been clearly demonstrated. In this population of fluctuating patients, the data would suggest that the pump out-performs standard medical therapy. The study did not enroll patients with severe dyskinesia, and it is unclear how the continuous infusion pump will perform in more severe and more disabled Parkinson’s disease patients.
One of the major drawbacks to the pump approach is the need for a percutaneous gatrojejunostomy (a small feeding tube). These types of tubes can serve as nidus points for infections and other complications, and in the current study, device complications were present in 89% of subjects. The complications were addressable in most cases, and were reported as lower than in previous pump trials.
Patients should be aware that the current version of the pump requires wearing an external device, and it also requires changing a dopamine cassette once or twice a day. The dopamine cassettes are a little smaller than a cellular phone, and usually last about 14-16 hours. Some patients will require two cassettes, and some will need additional medications during the bedtime hours. The pumps require continuous maintenance and programming by a qualified professional. The tube connected to the stomach also requires constant monitoring for infection.
If the continuous infusion approach receives FDA approval one important step will be to compare its effectiveness to that of deep brain stimulation therapy (DBS). Patient selection for pumps versus DBS will be an immediate and critical unmet need. One question will be whether the pump technology can help debilitated patients with and without cognitive dysfunction who may be excluded from DBS.
Patients should be aware that pumps are powerful symptomatic therapies, but not cures; and in most cases the continuous infusion pump will not address the dopamine resistant symptoms of walking, talking, and thinking. Pumps have not been shown to delay disease progression. The good news for the Parkinson’s disease community is that for a subset of patients a “pill free existence” may be on the horizon.
Posted: 2/3/2014 8:39:29 AM by
Browse current and archived What's Hot in PD? articles, the National Parkinson Foundation's monthly blog for people with Parkinson's written by our National Medical Director, Dr. Michael S. Okun.
Two New Therapies for Parkinson’s Disease Patients to get Excited About: Vaccines and Monoclonal Antibodies
The Importance of a Monitoring Strategy When Prescribing Dopamine Agonists: Lessons from the National Parkinson Foundation Data
Is Midlife Migraine Related to Late Life Parkinson’s Disease?
Deep Brain Stimulation for Parkinson’s Disease: NPF Congratulates Mahlon DeLong and Alim-Louis Benabid and Looks to a Bright Future in Human Neural-Network Modulation
Everything You Need to Know About Medical Marijuana and Parkinson’s Disease
The End for Levodopa Phobia: New Study Shows Sinemet is a Safe Initial Therapy for Treatment of Parkinson's Disease
Is light therapy a potential treatment modality in Parkinson’s disease?
How does the most common genetic cause of Parkinson’s Disease (LRRK2) cause Parkinson’s disease and could it be used to help develop a better therapy?
An Update on DAT Scanning for Parkinson’s Disease Diagnosis
Could Northera (Droxidopa) Be an Alternative Treatment for Low Blood Pressure and Passing Out Symptoms?
The Dream of a Pill Free Existence and the Continuous Dopaminergic Pump for the Treatment of Parkinson's Disease
Should I take Inosine to Raise my Uric Acid Levels and Treat my Parkinson’s Disease?
Could Fungus and Mold be an Important Contributor to Parkinson’s Disease?
Pimavanserin and the Hope for a Better Drug for Hallucinations and Psychosis in Parkinson’s Disease
Halting of the Creatine Study
The Importance of Identifying and Treating Caregiver Strain
Putting Parkinson’s Disease Information into the Palm of Your Hand: Parkinson’s Enters the Smartphon
What Parkinson’s Disease Patients Need to Know about H. Pylori Gastrointestinal Infections
A2A Receptor Antagonists and Parkinson’s Disease Treatment
Another Setback for Trophic Factor Treatment in Parkinson's Disease
IPX066 and What Patients Really Want in New Carbidopa/Levodopa (Sinemet) Formulations
The Weather Forecast for Parkinson’s Disease Calls for Worldwide Economic Storm
Defeating the Barriers to Implementing Exercise Regimens in Parkinson’s Disease Patients
When should you start medication therapy for Parkinson’s disease?
Neurologist Care Reduces Hospitalizations in Parkinson's Disease
A Victory in Court for Parkinson's Disease Patients who Require Ongoing Rehabilitative Therapies
Given the recent FDA announcement about Mirapex (pramipexole), should I be worried about dopamine agonists?
What about the new Parkinson’s Disease Vaccine? What should I know?
Caffeine as a Potential Treatment for Parkinson’s Disease
Time to Consider GPi DBS for Parkinson’s Disease: A Shift in the Practice of Patient Selection for DBS
A New Treatment for Parkinson’s Disease-Related Constipation
Too Many Pills: Improving Delivery Systems for Parkinson’s Disease Drugs
Measuring Quality and Assessing Depression in Parkinson's Disease
Watch out for Unexpected Obstacles if You Use a Cueing Strategy to Break Freezing of Gait in Parkinson’s Disease
Pill Color, Generic Medications and Insurance Issues: Important Medication-Related Tips for the Parkinson’s Disease Patient
Are Blood Tests for Parkinson’s Disease on the Horizon?
Placing Stem Cells in Animal Models of Parkinson’s Disease: Another Important Step
Important News for the Parkinson’s Disease Community: More Evidence that Sinemet and Madopar are Not Toxic and do Not Accelerate Disease Progression
The Case for All Parkinson’s Disease Patients to be Co-managed by a Primary Care-Neurologist Team
Scientists say Research on Brain Proteins Involved in Parkinson’s Disease is “Shaping” Up
Who Actually Takes Care of Most of the Parkinson’s Patients Worldwide: The Need for Education and the Parkinson’s Toolkit
If you are Dizzy or Passing Out, it could be Your Parkinson’s Disease or Parkinson’s Disease Medications
How Will Group Visits for Parkinson’s Disease Fit into the Future of Parkinson’s Disease Care?
Why Patients Should be Wary of Chelation Therapy for Parkinson’s Disease
Opening the Door to Gene Therapy in Parkinson’s Disease: The Need for Refinement of the Technology and Approach
Does it Matter if I Can’t Get Brand Sinemet?
Should I get a DaTscan or PET scan to confirm my diagnosis of Parkinson’s disease?
A Critical Reappraisal of the Worst Drugs in Parkinson’s Disease
Environmental Risks for PD: Manganese, Welding, Mining, and Parkinsonism
Calling for the FDA to Revise the Eight Sinemet a Day Rule
Dry Cleaning Solvents and Potential Environmental Risks for Developing Parkinson’s Disease
Maintaining the Balance: Why Parkinson’s Disease Patients Need to Understand Drug Recalls, Withdrawals, and Safety Alerts
Shining a Light on Parkinson’s Disease: Optogenetics Has a Bright Future in Research
Poor Medication Management of Parkinson's Disease During Hospital Admissions: Patients and Families Can Improve Their Hospital-Based Management
Why Are Patches and Continuous Release Technology a Big Deal to Parkinson's?
Is the PD SURG Trial Another Surge Forward for DBS Therapy?
Cycling in PD in Those Who Can’t Walk: Is it Possible?
New iPS Stem Cells for PD: What Does it Mean?
Time for Comprehensive Care Networks for PD
Is Parkinson's Disease a Prion Disease?
Parkinson's Disease Linked to Gaucher's Disease
Brain Cells Keep Time Stamps: Implications for Parkinson's Disease Therapies
Is it Safe to Have an MRI with a DBS in Place?
Take Care of Your Bones as They Are Affected in Parkinson's Disease (Even in Men)
Is it Time to Start Paying Attention to Pain Symptoms in Parkinson's Disease Patients?
Glutathione Fails to Demonstrate Significant Improvement in PD Symptoms
Keeping an Eye on Trials Important to the Parkinson's Disease Patient
Increased Risk of Melanoma in Parkinson's Disease
Finally a DBS Expert Consensus Statement Aimed at Their True Customers: The Patients
Pesticides and Environmental Exposure in Parkinson's disease: Should We Stay Away From the Stink Truck?
Is Exercise Effective Treatment and Protection Against PD?
Why are Transplant Trials Struggling to Succeed in the Treatment of PD?
Are Monoamine Oxidase Inhibitors Disease Modifying or Neuroprotective in PD?
Update on Gene Therapy for Parkinson's Disease